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15 April 2024
Clinical Evaluation Reports: General Structure and What to Include
21 April 2024MDCG 2022-9 Rev. 1 was published yesterday, with minor changes. It is available: HERE
Overview of Changes
The following sections were revised:
| Section | Changes |
|---|---|
| Introduction | Clarification on when the SSP should be made available to patients and elimination of footnote 3 |
| Footnote 2 | In line with MDCG 2019-9 rev.2* |
| Section 1A | “Indication whether it is a device for near-patient testing and/or a companion” moved from point 1.7 to point 2.3 |
| Sections 1A, 1B and 2 | ”Intended use of the device” was replaced by ”Intended purpose and other indications” in point 2. |
*As of today (16 April 2024) MDCG 2019-9 rev.2 is not available. The list of published MDCG endorsed guidance documents only lists MDCG 2019-9 rev.1 (dated March 2022).
Below we have provided a detailed overview of the changes to each section of MDCG 2022-9 Rev.1.
Introduction – Revisions
NOTE: words struck out were deleted. Words italicized were newly added in Rev.1.
If the device is not intended for self-testing, the SSP should have a first part be dedicated to the professional user. When relevant3, a second part dedicated to patients/lay persons should be added. It should be Furthermore, where the manufacturer considers it relevant to provide an SSP for patients, a part dedicated to patients and written in a way that is clear to lay persons should be added. The SSP template for devices not intended for self-testing is presented in Section 1.
3For devices that could be considered to have a more direct impact on an individual patient e.g. devices intended for diagnosis or as aid to diagnosis.
Footnote 2 – Revisions
NOTE: words struck out were deleted. Words italicized were newly added in Rev.1.
2 When the The manufacturer should verify whether updates of its PMPF evaluation report (Article 56(6)) and the periodic safety update report (PSUR, Article 81 (1)) are updated at least annually, the SSP shall be reviewed and updated require also an update of the SSP.
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Section 1A – Revisions
The statement “indication whether it is a device for near-patient testing and/or a companion” was:
- Moved from section 1 “Device identification and general information”
- to Section 2 (now called) “Intended purpose and other indications”.
Sections 1A, 1B and 2
The term “Intended use of the device” has been replaced with “Intended purpose and other indications”, in the following sections:
- Section 1A – Summary of safety and performance for professional users
- Section 1B – Summary of safety and performance for patients/lay persons
- Section 2 – SSP Template for self-testing devices
Further Reading
The following topics may be of interest:
